Type-II diabetes mellitus (DM) is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency and hyperglycemia. It is rapidly increasing in the developed countries and there is also evidence that this pattern will be followed in much of the rest of the parts of the world in coming years. About 90-95% of all North Americans are suffering from type-II diabetes and 20% of the population are over the age of 65 years. Diabetes affects over 150 million people worldwide and this number is expected to double by 2025. Now it has been proven that the Islet Amyloid Polypeptide genes are responsible for the early on set of type-II diabetes.
Type II diabetes is the predominant form of diabetes accounting for 90% of case globally. In type II diabetes, two impairments are found to increase blood glucose levels; impaired insulin action and impaired pancreatic insulin secretion. In addition, liver also plays key role in adjusting blood glucose levels via. gluconeogenesis in fasting and glucogenolysis in postprandial conditions. In type II diabetes glucogenolysis increases disproportionally which further contribute in elevated blood glucose level.
About 55% patients of type-II diabetes mellitus are obese, with the result obesity leads to increased insulin resistance that can develop into diabetes. Further, type-II diabetes mellitus often associated with obesity, hypertension and dyslipidemia. Additional factors founds to be associated with type-II diabetes include ageing, high fat diets and less active life style.
Diabetes is associated with factors which directly contribute to cardiovascular disorders including insulin resistance, dyslipidemia, atherosclerosis, hypertension, excessive oxidations, endothelial dysfunction, vascular inflammation and growth factors may affect platelet aggregation. Obesity is another risk factor in the development of diabetes and CHD.
Both diabetes and impaired glucose tolerance are associated with increased risk of reno-Cardio vascular diseases (CVD). Approximately 80% of death in diabetes patients are due to CVD which is significantly associated with dyslipidemia.
Inflammation plays a vital role in pathogenesis of CHD among diabetes patients. Interleukin-6 and C-reactive protein are scientific bio-markers associated with hyperglycemia, insulin resistance and type-2 diabetes mellitus. Both the factors are responsible for development of cardiovascular disorders. IL-6 has been shown to induce gluconeogenesis subsequently hyperglycemia and hyperinsulinemia. Levels of CRP are increased in type-2 diabetes and can cause CHD death independently. Hyperhomocysteinemia (Hyper Hcy) is also recognized as independent risk factor for CVD in type-2 diabetes. Hyper Hcy exerts toxic effects via elevated oxidative stress which induces endothelial dysfunction. In addition adipokine leptin has been found to be positively associated with insulin resistance, diabetes risk, triglyceride level, CRP, blood pressure, obesity etc. Adiponectin, a protein secreted by adipose cells regulates insulin sensitivity with energy metabolism. A decreased level of adiponectin concentration is recorded in above conditions. Recently peroxisome proliferator activator receptor (PPAR-α)-α and PPAR-γ are found to be associated with diabetes that regulated insulin responsive gene transcription involved in glucose production, transport and utilization.
The available oral anti-hyperglycemic drugs are in practice for the management of diabetes but application of these agents is limited because of adverse reaction of these synthetic chemicals.
Similarly treatment with statin for dyslipidemia causes risk of hepatic or muscle enzyme abnormalities.
Keeping the above facts in view it was thought to propose a plant based formulation showing beneficial role in the management of type-2 diabetes mellitus and associated disorder. In Ayurvedic system of medicine, several plants have been advocated for their hypoglycemic effects and are still in practice. Taking the lead from ancient literature four plants Salacia roxburghii (Saptarangi), Salacia oblonga, Garcinia indica (Kokum) and Lagerstroemia parviflora (Jarul) were selected out of various screened plants carried out for this purpose and the novel formulation was prepared following standard norms.
In experimental studies the safety and efficacy profile of single plant candidate and also combined formulation has been established. The test drug was found to have an agonist for PPAR activated receptor and regulates insulin responsive gene transcription involved in glucose production, transport and utilization and thus reduced blood glucose and reduces hyper-insulinemia. Our claims are established on the basis of experimental and clinical trials.